A Study of Bimatoprost 0.01% in the Clinical Setting (APPEAL-Taiwan)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01814761
First received: March 18, 2013
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP).


Condition Intervention Phase
Glaucoma, Primary Open Angle
Ocular Hypertension
Drug: Bimatoprost 0.01%
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients With Ocular Hyperemia [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Who Discontinue Due to an Adverse Event [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pts with POAG or OH
Patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
Drug: Bimatoprost 0.01%
One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every evening for 12 weeks.
Other Name: Lumigan® 0.01%

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with primary open-angle glaucoma or ocular hypertension

Criteria

Inclusion Criteria:

  • Diagnosis of primary open-angle glaucoma or ocular hypertension
  • Determined by the treating physician to require treatment with bimatoprost 0.01%.

Exclusion Criteria:

  • Previous use of Lumigan® 0.01%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01814761

Locations
Taiwan
Taichung City, Taiwan
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01814761     History of Changes
Other Study ID Numbers: GMA-AP-EYE-AGN-001
Study First Received: March 18, 2013
Last Updated: June 25, 2014
Health Authority: Taiwan: Center for Drug Evaluation

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Glaucoma, Open-Angle
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Bimatoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 09, 2014